Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial

The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.

Study Overview

• Status: Recruiting
• Conditions: Stage IA Lung Cancer
• Intervention / Treatment: Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system; Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system

Detailed Description

This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: xkyyjysun@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: xkyyjysun@163.com
      • Principal Investigator: Jiayuan Sun, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age greater than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

Exclusion Criteria:

1. Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
2. Patients with severe pulmonary fibrosis and pulmonary hypertension.
3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
5. Patients with poorly controlled malignant pleural effusion.
6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5~7 days before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score > 2.
8. Combined with other tumors with extensive metastasis, expected survival < 6 months.
9. Patients with episodic psychosis.
10. Patients with implantable electronic devices (such as pacemaker or defibrillator).
11. Pregnant women, or patients who have pregnancy plans during the study.
12. Participation or ongoing participation in another clinical study within the past 30 days.
13. Other situations that the investigator deems inappropriate to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transbronchial group; Subjects receive bronchoscopy-guided RFA and undergo follow-up.	Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system; Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
Experimental: Transthoracic group; Subjects receive CT-guided RFA and undergo follow-up.	Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system; Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ablation rate at 6 months after ablation	It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.	Immediately after ablation
Complete ablation rate 12 months after ablation	It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.	12 months
Local control rate at 1 year, 2 years and 3 years after ablation	It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.	1 year, 2 years and 3years
Progression free survival (PFS)	It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.	3 years
Overall survival (OS)	It is defined as the total time from the ablation to the death of the subject.	3 years
Safety	To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.	12 months

Collaborators and Investigators

• Sponsor: Hangzhou Broncus Medical Co., Ltd.
• Collaborators: Shanghai Chest Hospital
• Investigators: Principal Investigator: Jiayuan Sun, MD, PhD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: BC-I-RF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No